Daratumumab + Lenalidomide + Dexamethasone for Multiple Myeloma

Palo Alto (17 mi)

Overseen byPaul Richardson, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who've had 2-4 prior treatments and can receive lenalidomide and dexamethasone. Candidates must have an ECOG performance status of 0-2, indicating they are fully active or at least ambulatory. Those with a history of certain stem cell transplants, recent cancer treatments, or adverse reactions to lenalidomide aren't eligible.

Inclusion Criteria

My multiple myeloma has returned after 2-4 treatments, and I can be treated with Len/Dex.

I have been treated for multiple myeloma before.

I can take care of myself and am up and about more than half of my waking hours.

I am 18 years old or older.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I had a stem cell transplant using my own cells within the last 3 months.

Treatment Details

The study tests the safety of daratumumab combined with lenalidomide and dexamethasone in those whose multiple myeloma has returned after treatment. It's structured in two parts: first determining the safe dosage (dose escalation) and then assessing its effectiveness at that dose (dose expansion).

1Treatment groups

Experimental Treatment

Group I: DaratumumabExperimental Treatment4 Interventions

Participants will receive daratumumab along with Lenalidomide and dexamethasone.

Daratumumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Darzalex for:

Relapsed and refractory multiple myeloma
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

🇺🇸 Approved in United States as Darzalex for:

Multiple myeloma in patients who have received at least three prior therapies
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone